BEUDAMED
    FDA Recall Open, Classified

    Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.

    Recall: Z-1778-2022 · Initiated August 24, 2022

    Recall

    Recall Number
    Z-1778-2022
    Event Number
    90836
    Firm
    Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    KRQ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 24, 2022
    Posted
    September 23, 2022
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.

    Reason

    A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.

    Action

    On August 24, 2022, the firm sent written notification (Product Field Action) to the single affected customer to document the event. The customer was asked to confirm their receipt of the notice.

    Distribution

    Distributed to one customer located in New York.

    Quantity

    1 unit